A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-981 in Patients With Osteoarthritis of the Knee
- Conditions
- Osteoarthritis
- Interventions
- Biological: ABT-981Biological: Placebo
- Registration Number
- NCT01668511
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with osteoarthritis of the knee.
- Detailed Description
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Thirty-six patients with osteoarthritis of the knee will be selected to participate. Patients will be randomized to receive either ABT-981 or placebo. ABT-981 or placebo will be administered as subcutaneous (under the skin) injections in four dosing groups. Subjects will be administered subcutaneous injections of ABT-981 for up to 8 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Adult male or female, 40 to 70 years of age, inclusive.
- History of symptomatic osteoarthritis (OA) of the knee joint for at least 3 months, with typical Osteoarthritis (OA) symptoms
- Radiographic Osteoarthritis (OA) of Kellgren-Lawrence (K-L) grade 1, 2 or 3
- Patients assessment of Osteoarthritis (OA) pain intensity of the study joint is between 40 and 80 on the 0 - 100 mm VAS scale
- Other than Osteoarthritis (OA) of the study joint, patient should be in general good health
- Radiographic OA of Kellgren-Lawrence grade 4 or chronic opioid user due to severe knee OA
- History of allergic reaction or significant sensitivity to any constituents of the study drug and acetominophen or history of anaphylactic reaction to any agent
- Significant trauma or surgery to the study joint within the last year or arthroscopy within 6 months, or, scheduled for major surgery to the study joint
- Diagnosis of rheumatoid arthritis, other autoimmune disorders or any arthritis other than Osteoarthritis (OA) of the knee.
- Any uncontrolled medical illness including unstable treatment or therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 ABT-981 Randomized 7 drug/2 placebo by group Group 1 Placebo Randomized 7 drug/2 placebo by group Group 3 ABT-981 Randomized 7 drug/2 placebo by group Group 3 Placebo Randomized 7 drug/2 placebo by group Group 4 Placebo Randomized 7 drug/2 placebo by group Group 2 Placebo Randomized 7 drug/2 placebo by group Group 4 ABT-981 Randomized 7 drug/2 placebo by group Group 1 ABT-981 Randomized 7 drug/2 placebo by group
- Primary Outcome Measures
Name Time Method Physical Exam including vital signs From date of first dose of ABT-981 until 70 days after last dose of ABT-981 Blood pressure, heart rate and body temperature
Clinical Lab Testing From date of first dose of ABT-981 until 70 days after the last dose of ABT-981 Hematology, Chemistry, and Urinalysis
Time to Cmax (Tmax) of ABT-981 Prior to first dose up to 70 days after the last dose of ABT-981 Time to Cmax
The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981 Prior to the last dose up to 70 days after the last dose of ABT-981 The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981
Number of participants with Adverse Events From date of first dose of ABT-981 until 70 days after the last dose of ABT-981 Collect all adverse events at each visit
Maximum observed serum concentration (Cmax) of ABT-981 Prior to first dose up to 70 days after the last dose of ABT-981 Cmax
Change from Baseline in Electrocardiogram (ECG) Prior to dose and 8 hours post dose on each day of dosing ECGs done in triplicate
The area under the time curve (AUC) of ABT-981 Prior to first dose up until 70 days after the last dose of ABT-981 AUC
- Secondary Outcome Measures
Name Time Method Measurement of anti-drug anti-bodies (ADA) of ABT-981 Prior to each dose and up until 70 days after the last dose of ABT-981 Measurement of ADA
Trial Locations
- Locations (1)
Site Reference ID/Investigator# 78613
🇺🇸Miami, Florida, United States